APPLIED EPIDEMIOLOGY FOR REAL-WORLD EVIDENCE

OBJECTIVES

To understand the basic concepts and principles in epidemiology

To become familiar with the epidemiological tools that could be used in pharmacovigilance and pharmacoepidemiology

To understand the specificity of epidemiological tools applied to pharmacovigilance and pharmacoepidemiology

MODULE PARTS

• Descriptive epidemiology (person, place and time)
• Observational studies in pharmacoepidemiology
• Biases in pharmacoepidemiology studies
• Causality criteria, evidence level and critical reading

TRAINER TEAM

Coordinator: Prof Antoine Pariente (Université de Bordeaux)

Experts: Prof Francesco Salvo, Adeline Degremont (Université de Bordeaux)

BIOSTATISTICS FOR DRUG DEVELOPMENT AND REGULATORY DECISION-MAKING

OBJECTIVES

To understand applications of probability in statistics

To understand how to organize and describe epidemiological data

To understand how to perform data estimations, comparisons and predictions

To understand how to estimate the sample size and power of epidemiology studies

To introduce the principles of multivariable comparisons

MODULE PARTS

• Introduction to statistics and probability
• Estimates
• Statistical testing
• Introduction to multivariable linear regression

TRAINER TEAM

Coordinator: Dr Karine Palin (Université de Bordeaux)

Experts: Prof Francesco Salvo, Frederic Daoud (Université de Bordeaux)

FOUNDATIONS OF RISK COMMUNICATION IN HEALTHCARE

OBJECTIVES

To know the basic principles of communication and to gain an insight into the characteristics of effective communication

To face to the complexity communication on risk for health

To know the evolution of medicine risk communication

MODULE PARTS

• Which knowledge and skills are useful for communication?
• Concrete examples of communication: what do we retain?
• Why communicate? Nature and importance of communication. Personal and social dimension of communication
• Face to face between doctor and patient. How to find the right word?

TRAINER TEAM

Coordinator: Prof Annalisa Capuano (Università degli Studi della Campania Luigi Vanvitelli)

Experts: Christa Naboulet, Dr Marie-Pierre Barrouillet (Université de Bordeaux), Bruce Hugman (Independent), Dr Cristina Scavone, Dr Annamaria Mascolo, Prof Liberata Sportiello, Dr Cecilia Cagnotta, Dr Antonietta Anatriello (Università degli Studi della Campania Luigi Vanvitelli)

CLINICAL PHARMACOLOGY FOUNDATIONS FOR DRUG DEVELOPMENT

OBJECTIVES

To understand the role of medicines in therapeutics, health services and society

To become familiar with the life cycle of medicines and the regulatory aspects of medicines market

To review the clinical and pharmacological basis of prescribing

To understand the need to evaluate the effects of medicines from an epidemiological perspective

To understand the relevance of unbiased information to ensure the appropriate use of medicines

To discuss the need to monitor medicines prescribing process

MODULE PARTS

• Clinical pharmacology. Aims and uses in the therapeutics.
• Clinical pharmacology and epidemiological evaluation of medicine effects
• The randomized clinical trials (RCT) as a method for assess the efficacy of medicines
• Basics for RCT appraisal: extrapolation of RCTs results to clinical practice.

TRAINER TEAM

Coordinator: Dr Antònia Agustí (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Lina Camacho (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Dr Ulf Bergman (Karolinska Institutet)

GLOBAL PHARMACOVIGILANCE SYSTEMS AND DRUG SAFETY MANAGEMENT

OBJECTIVES

To enable you to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-authorisation environment and the roles of various stakeholders within pharmacovigilance.

MODULE PARTS

• Introduction to pharmacovigilance principles.
• Safety evaluation during a products lifecycle.
• Labelling and risk management.

TRAINER TEAM

Coordinator: Sue Rees (University of Hertfordshire)

Experts: Dr Sherael Webley, Dr Christopher Benham, Jabeen Ahmadi (University of Hertfordshire), Wendy Brewster, Steve Hobbiger (GlaxoSmithKline Research and Development Ltd), Dr David Lewis (Novartis Pharma AG), Shelley Ghandi (NDA Regulatory Science), Dr James Whitehead (AstraZeneca AB)

APPLIED PHARMACOEPIDEMIOLOGY AND REAL-WORLD DATA ANALYSIS

OBJECTIVES

To understand how to evaluate the effects of medicines and therapeutic interventions both during drug development and clinical use

To know the main methodological and ethical characteristics and limitations of randomized clinical trials

To understand the differences between efficacy and effectiveness

To know the basic concepts and classification of the pharmacoepidemiological studies designed to evaluate therapeutic interventions

To identify information gaps in selected therapeutic areas (e.g. cardiovascular, psychiatry, diabetes care)

MODULE PARTS

• Patients, medicines and prescribing in society. Life cycle of medicines.
• The knowledge-building process of the effects and adverse effects of medicines during their development and clinical use.
• Overview of studies to detect and to evaluate the risk associated with therapeutic interventions. Scope, uses and limitations.
• The need to monitor the medicines prescribing process.
• Introduction to the study of the use of medicines in clinical practice.

TRAINER TEAM

Coordinator: Dr Imma Danés (Universitat Autònoma de Barcelona)

Experts: Janice Fuller (Amgen NV), Prof Joan-Ramon Laporte, Josep Maria Castel, Dr Eduard Diogène, Dr Antònia Agustí, Dr Xavier Vidal, Melani Nuñez Montero (Universitat Autònoma de Barcelona), Prof Albert Figueras (World Health Organization), Noah Jamie Robinson (F. Hoffmann-La Roche Ltd), Dr Ulf Bergman (Karolinska Institutet), Lucia Bellas Fernández (European Health Data and Evidence Network)

CRITICAL APPRAISAL AND VALUE OF SCIENTIFIC EVIDENCE

OBJECTIVES

To improve your scientific communication skills such as:

• Redaction of scientific original papers and reports
• Realization of a scientific poster
• Preparation of a scientific oral communication

To become familiar with the institutions and data sources in Health Sciences

To become familiar with the research funding

MODULE PARTS

• Critical reading of scientific literature: clinical trials and observational studies
• Principles of the redaction of scientific papers and reports
• Introduction to scientific watch: principles and techniques
• Principles of scientific posters and oral communication
• Presentation of the main institutions and data sources in Health Sciences
• Principles for research funding

TRAINER TEAM

Coordinator: Dr Karine Palin (Université de Bordeaux)

Experts: Christa Naboulet, Stéphane Liège, Prof Francesco Salvo (Université de Bordeaux), Dr Yannick Arimone (Agence Nationale pour la gestion des Déchets RAdioactifs)

ANALYSIS AND SYNTHESIS OF HEALTH DATA

OBJECTIVES

Synthesize in a consistent manner available information related to a pharmacoepidemiological problem from different data sources.

TRAINER TEAM

Coordinator: Prof Francesco Salvo (Université de Bordeaux)

Experts: Prof Antoine Pariente (Université de Bordeaux)